Opinion of Mr Advocate General Mancini

Mr President,

Members of the Court,

1. In this reference for a preliminary ruling the Court is asked to interpret Council Directive 65/65/EEC of 26 January 1965 (Official Journal, English Special Edition 1965-1966, p. 20) on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products. It is a question, essentially, of establishing whether rules which regulate the prices of pharmaceutical products in some way fall within the scope of that directive.

2. I shall begin by considering briefly the contested provisions. As is clear from its title, the ministerial order of 10 February 1976 is intended to regulate the prices of proprietary medicinal products and other drugs. It provides that proprietary medicinal products and certain other drugs may not be sold to wholesalers, dispensing chemists and hospital establishments at prices higher than those charged on 11 August 1975 (Article 1); it fixes the maximum profit margins of wholesalers and dispensing chemists on sales of proprietary medicinal products (Article 2); it provides that, before marketing new products (namely, those not yet on the market on 11 August 1975), manufacturers and importers must obtain approval from the competent authority (the Minister for Economic Affairs) for the price which they intend to charge (Article 3). We are therefore dealing with rules which are concerned directly and exclusively with the prices of pharmaceutical products and which consequently fall within the ambit of national economic policy in the wide sense of the term.

3. I shall now examine the three questions on which the Court is requested to give a ruling. At the heart of the case is the second question, which concerns the scope of Directive 65/65: the national court wishes to know whether it covers only rules which are concerned with the protection of health or whether it also applies to rules relating to prices. Logically, that question must be answered before Question 3, which concerns the interpretation of a single provision of the directive, and before Question 1, which asks what effect the various provisions of the directive have. In fact if Question 2 is answered in the negative, a similar answer will have to be given to Question 3, while Question 1 will become irrelevant.

4. I will now consider the question relating to Article 21 of Directive 65/65, which provides that: An authorization to market a proprietary medicinal product shall not be refused, suspended or revoked except on the grounds set out in this directive. The Belgian Conseil d'État asks whether that rule should be interpreted as meaning that an authorization may be refused, suspended or revoked on the ground that national rules on prices have not been complied with. The reply which I have given to the first question contains the criteria needed to resolve this second question. If it is indeed accepted that rules on prices are outside the scope of the directive, it must also be acknowledged that the failure to comply with such rules does not entitle the competent authorities to refuse, suspend or revoke an authorization.

5. Finally, by the third question, the Conseil d'État asks whether Directive 65/65 has direct effect in the Member States and consequently whether individuals may rely upon its provisions before the national courts. The reply which I have given to the preceding questions makes it unnecessary to decide this question, which is too general (since the directive consists of 25 articles). Once it is accepted that national measures relating to prices are outside the scope of the directive, there is no purpose in determining whether or not the provisions of that directive have direct effect.

6. On the basis of all the considerations set out above, I suggest that the Court should reply to the second and third questions asked by the Belgian Conseil d'État by judgment of 22 October 1982 in the action brought by SA Clin-Midy and 13 other undertakings in the pharmaceuticals sector against the Belgian State:

1 Translated from the Italian.